BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESTEEM

    MDR report key: 3885829 · Received June 10, 2014

    Report

    Report Number
    3004007782-2014-00015
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    January 10, 2014
    Report Date
    June 5, 2014
    Manufacturer
    ENVOY MEDICAL
    Product Code
    OAF
    PMA / PMN Number
    P090018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    (B)(6) 2008 - ORIGINAL IMPLANT SURGERY. (B)(6) 2013 - NORMAL BATTERY CHANGE SURGERY REPLACED THE SOUND PROCESSOR (SP). FOUR MONTHS LATER, PATIENT EXPERIENCED WOUND DEHISCENCE, AND RECEIVED A COURSE OF ANTI-BIOTICS. (B)(6) 2014 - THE ESTEEM SYSTEM WAS EXPLANTED TO ALLOW FOR HEALING AND TREATMENT OF INFECTION. NO FCE HAD BEEN PRESENT. (B)(6) 2014 - DEVICE RECEIVED BY FCE. (B)(4) 2014 - DEVICE RECEIVED BY ENVOY MEDICAL FOR EVALUATION. (B)(6) 2014 - POST MARKET SURVEILLANCE BROUGHT THIS OUS CASE TO ATTENTION AS REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341387 ESTEEM OAF ENVOY MEDICAL 2001 EMC0005156

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other